FARXIGA PI PDF

This medicine is authorised for use in the European Union. Overview Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough. In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin another diabetes medicine. Forxiga contains the active substance dapagliflozin. Expand section Collapse section How is Forxiga used?

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This medicine is authorised for use in the European Union. Overview Forxiga is a diabetes medicine used for adults whose condition is not controlled well enough. In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin another diabetes medicine. Forxiga contains the active substance dapagliflozin. Expand section Collapse section How is Forxiga used? Forxiga is available as tablets 5 and 10 mg and can only be obtained with a prescription.

For type 2 diabetes, the dose of Forxiga is 10 mg once a day. If it is used with insulin or medicines that help the body produce insulin, the doses of these medicines may need to be reduced to decrease the risk of hypoglycaemia low blood sugar levels.

For type 1 diabetes, treatment with Forxiga should be started and supervised by a specialist in type 1 diabetes. The dose is 5 mg once a day and the medicine should be used with precautions to prevent diabetic ketoacidosis a serious complication of diabetes with high levels of ketones in the blood.

For more information about using Forxiga, see the package leaflet or contact your doctor or pharmacist. How does Forxiga work? Diabetes can occur when the body does not make enough insulin to control the amount of glucose sugar in the blood or when the body cannot use insulin effectively.

This leads to high levels of glucose in the blood. The active substance in Forxiga, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 SGLT2. By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.

What benefits of Forxiga have been shown in studies? Forxiga was found effective in several studies in patients with type 2 and type 1 diabetes. The main measure of effectiveness was the level of glycosylated haemoglobin HbA1c , which gives an indication of how well blood glucose is controlled. Type 2 diabetes In two studies involving patients with type 2 diabetes, Forxiga when used alone decreased HbA1c levels by 0.

In four other studies involving 2, patients, adding Forxiga to other diabetes medicines decreased HbA1c levels by 0. In a study involving patients with type 2 diabetes, Forxiga used in combination with metformin was at least as effective as a sulphonylurea another type of diabetes medicines used with metformin.

Both combinations reduced HbA1c levels by 0. A long-term study, involving over 17, patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular heart and circulation disease. Type 1 diabetes In two studies involving 1, patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Forxiga 5 mg decreased HbA1c levels after 24 hours by 0.

What are the risks associated with Forxiga? The most common side effect with Forxiga in patients with type 2 diabetes which may affect more than 1 in 10 people is hypoglycaemia, especially when used in combination with a sulphonylurea or insulin. The most common side effect in patients with type 1 diabetes which may affect up to 1 in 10 people is genital infection, especially in women and a common side effect which may affect up to 1 in people is diabetic ketoacidosis. For the full list of side effects and restrictions with Forxiga, see the package leaflet.

Why is Forxiga authorised in the EU? The European Medicines Agency considered that Forxiga was effective for treating type 2 diabetes when given alone or in combination with other diabetes medicines which work in different ways.

Adding Forxiga to insulin treatment in patients with type 1 diabetes whose diabetes could not be controlled well enough with insulin was also effective. In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Forxiga.

Forxiga increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and it is recommended for this condition only in overweight and obese patients.

The Agency concluded that the benefits of Forxiga outweigh its risks and recommended that it be granted marketing authorisation. What measures are being taken to ensure the safe and effective use of Forxiga?

The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with Forxiga. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Forxiga have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Forxiga are continuously monitored. Side effects reported with Forxiga are carefully evaluated and any necessary action taken to protect patients. Other information about Forxiga.

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Assess and correct volume status before initiating FARXIGA in patients with impaired renal function, elderly patients, or patients on loop diuretics. Some cases were fatal. Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. Elderly patients and patients with impaired renal function may be more susceptible to these changes. Consider temporarily discontinuing in settings of reduced oral intake or fluid losses Before initiating FARXIGA, evaluate renal function and monitor periodically. Cases have been reported in females and males. Serious outcomes have included hospitalization, surgeries, and death.

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Symptoms of a serious allergic reaction may include skin rash, raised red patches on your skin hives , swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away have severe kidney problems or are on dialysis. FARXIGA may cause serious side effects including: Dehydration the loss of body water and salt , which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up orthostatic hypotension. You may be at a higher risk of dehydration if you have low blood pressure; take medicines to lower your blood pressure, including water pills diuretics ; are 65 years of age or older; are on a low salt diet, or have kidney problems Ketoacidosis occurred in people with type 1 and type 2 diabetes during treatment with FARXIGA. Ketoacidosis is a serious condition which may require hospitalization and may lead to death.

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